Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy

• Conditions: Prostate Cancer; Hormone Refractory Prostate Cancer
• Interventions: Procedure: Phlebotomy

• Registration Number: NCT00133900
• Lead Sponsor: Immunicon

Brief Summary

This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen \[PSA\] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Status Verified: 2008-03
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-07-27
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 276

Inclusion Criteria

• Age > or = 18 years
• Pathological diagnosis of adenocarcinoma of the prostate
• First or later line of chemotherapy
• Serum testosterone < 50ng/mL
• ECOG 0-2
• Serum PSA > or = 5ng/mL
• PSA progression (2 rises above a reference value)
• Bone scan within 60 days of enrollment
• Computed tomography (CT) scan
• If measurable disease, bone scans every 6-8 months

Exclusion Criteria

• Systemic radiation
• Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
• Brain metastases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Phlebotomy	Metastatic Hormone Refractory Prostate Cancer Patients

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 36 months from time of baseline draw

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Up to 36 months after baseline draw

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States